The European Medicines Agency (EMA) and Head of Medicines Agency (HMA) have released a joint report with recommendations to unlock the potential of data in medicines regulation and improve public health.
Big data are very large accumulating data sets captured in multiple settings and through multiple devices such as wearable devices, electronic health records or clinical trials. Big data has the potential to complement evidence from clinical trials and “fill knowledge gaps” on different medicines and diseases.
The 10 priority recommendations listed below are designed to aid EU regulators in the collection, managements and interpretation of data, ensuring that data is managed and analysed within a secure and ethical governance framework.
- Deliver a sustainable platform to access and analyse healthcare data from across the EU
- Establish an EU framework for data quality and representativeness
- Enable data discoverability
- Develop EU Network skills in big data
- Strengthen EU Network processes for big data submissions
- Build EU Network capability to analyse big data
- Modernise the delivery of expert advice
- Ensure data are managed and analysed within a secure and ethical governance
- Collaborate with international initiatives on big data
- Create an EU big data “stakeholder implementation forum”
The report emphasises that, despite the promotion of big data, it is not the complete solution to all regulatory challenges. “Data from randomised controlled clinical trials will remain the reference standard for most regulatory use cases.”
Click here to take a look at the recommendations in more detail.